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  • FDA Date: 10/31/2013

    Iclusig (ponatinib) FDA Drug Safety Communication

    FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales

    This update is in follow-up to the FDA Drug Safety Communication: FDA investigating leukemia drug Iclusig (ponatinib) after increased reports of serious blood clots in arteries and veins issued on October 11, 2013.

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    The U.S. Food and Drug Administration (FDA) has asked the manufacturer of the leukemia chemotherapy drug Iclusig (ponatinib) to suspend marketing and sales of Iclusig because of the risk of life-threatening blood clots and severe narrowing of blood vessels. We will continue to evaluate the drug to further understand its risks and potential patient populations in which the benefits of the drug may outweigh the risks. Patients currently receiving Iclusig should discuss with their health care professionals the risks and benefits of continuing treatment with the drug.

    The drug manufacturer, Ariad Pharmaceuticals, has agreed to FDA's request to suspend marketing and sales of Iclusig while we continue to evaluate the safety of the drug. At this time, patients and health care professionals should follow FDA's new recommendations for the drug:

    -Patients currently taking Iclusig who are not responding to the drug should immediately discontinue treatment and discuss alternative treatment options with their health care professionals.

    -Patients who are currently taking Iclusig and responding to the drug and whose health care professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA's safety investigation continues. FDA will work with the manufacturer on a plan to quickly transition these patients to a program that will allow access under an IND or expanded access registry program.

    -Health care professionals should not start treating new patients with Iclusig unless no other treatment options are available and all other available therapies have failed. Upon the determination of their health care professional, these patients can be considered for treatment under an IND or expanded access registry program.

    FDA's recent investigation of Iclusig revealed an increased frequency of blood clots and narrowing of blood vessels since the drug was approved in December 2012. Currently, approximately 24 percent of patients (nearly 1 out of 4) in the Phase 2 clinical trial (median treatment duration 1.3 years) and approximately 48 percent of patients in the Phase 1 clinical trial (median treatment duration 2.7 years) have experienced serious adverse vascular events, including fatal and life-threatening heart attack, stroke, loss of blood flow to the extremities resulting in tissue death, and severe narrowing of blood vessels in the extremities, heart, and brain requiring urgent surgical procedures to restore blood flow. In some patients, fatal and serious adverse events have occurred as early as 2 weeks after starting Iclusig therapy. The Phase 1 and 2 clinical trials did not include a control group so it is not possible to determine the relationship of these adverse events to Iclusig, however the increasing rate and pattern of the events strongly suggests that many are drug-related. At this time, FDA cannot identify a dose level or exposure duration that is safe.

    In the Phase 2 clinical trial, adverse events affecting the blood vessels that supply the heart, brain, and extremities were observed in 12 percent, 6 percent, and 8 percent of patients, respectively. Patients with and without cardiovascular risk factors, including patients in their 20s, have experienced these events. Serious adverse reactions involving the eyes, which led to blindness or blurred vision, occurred in Iclusig-treated patients. High blood pressure occurred in 67 percent of patients treated with Iclusig in the clinical trials. Heart failure, including fatalities, occurred in 8 percent of patients treated with the drug.

    View the full FDA Drug Safety Communication on FDA.gov